🔍 RecallPedia

Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

Class I - Dangerous
🏥 Medical Devices Recalled: September 6, 2018 Stihler Electronic Gmbh Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: E22000 to E23999
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Stihler Electronic Gmbh
Reason for Recall:
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.

Product Codes/Lot Numbers:

Serial Numbers: E22000 to E23999

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0759-2019

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